Osteopathic Manipulative Treatment for Constipation in People With Rett

Status Completed

Clinical Trial Summary

Constipation consists of bowel symptoms characterized by difficulty or infrequency passage of stool, stiff stool, or a feeling of incomplete evacuation. However, its impact goes far beyond this definition. Constipation negatively impacts the quality of life (QoL) of children and adults suffering from this condition, affecting mental and physical-related QoL. Additionally, a negative impact of constipation on QoL was found in parents carrying children with constipation, affecting family functioning. People with an intellectual disability present a constipation rate of over 33%. Rett syndrome (RTT) is a complex neurodevelopmental disorder affecting about 1/10,000 females and a few males worldwide. Chronic constipation is persistent in people with RTT, with a reported prevalence higher than 74%. Specific recommendations for constipation management in RTT were developed, including behavioral, pharmacological, and surgical considerations. Recently, the literature has been enriched with papers describing the osteopathic treatment efficacy in reducing constipation. Emerging literature reported the efficacy of OMT in reducing constipation symptoms and improving QoL in typically developed people, as well as in children with disability. The present study aims to evaluate the efficacy of a specific OMT for managing chronic constipation in people with RTT and its impact on primary caregivers' quality of life. Research questions: - Can an OMT improve the constipation of people with RTT, increasing the frequency of bowel movements? - Can the effects of an OMT aimed at reducing the constipation symptoms in people with RTT positively impact the participants' parents' constipation-related QoL? Twelve individuals with RTT and their families will be recruited to participate in this single-blind parallel group-randomized study. Participants will be randomly divided into an experimental group (EG) and a control group (CG). After the preliminary evaluations, each participant will undergo eight OMT carried out weekly for eight weeks. The OMT will aim to facilitate bowel movements by increasing blood flow through the abdomen. At the end of the treatment, the participants will repeat the evaluation conducted before the OMT, and the collected data will be analyzed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05687214
Study type	Interventional
Source	Ariel University
Contact
Status	Completed
Phase	N/A
Start date	November 16, 2022
Completion date	January 27, 2023

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See also
Status	Clinical Trial	Phase
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Recruiting	`NCT04463316` - GROWing Up With Rare GENEtic Syndromes
Completed	`NCT04776746` - Open-Label Extension Study of Trofinetide for Rett Syndrome	Phase 3
Completed	`NCT04181723` - Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)	Phase 3
Enrolling by invitation	`NCT03836300` - Parent and Infant Inter(X)Action Intervention (PIXI)	N/A
Completed	`NCT04514549` - ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME
Terminated	`NCT02562820` - An Exploratory Trial of Ketamine for the Treatment of Rett Syndrome	Phase 1
Completed	`NCT02738281` - Natural History of Rett Syndrome & Related Disorders
Recruiting	`NCT06199700` - Esketamine for the Treatment of Rett Syndrome	Early Phase 1
Completed	`NCT03941444` - ANAVEX2-73 Study in Patients With Rett Syndrome	Phase 3
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms